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Extended release antibiotic composition

a technology of antibiotic composition and extended release, which is applied in the direction of antibacterial agents, biocide, coatings, etc., can solve the problems of extreme bitterness, and achieve the effect of reducing the variability of the plasma level of antibiotics

Inactive Publication Date: 2005-06-23
SANDOZ INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0014] The present inventors have determined that an antibiotic composition comprising a polymer component in an amount greater than 50 wt. %, based on the total weight of the composition, reduces the plasma level variability of the antibiotic over an extended period of time as compared to antibiotic compositions containing less than 50 wt. % of a polymer component.

Problems solved by technology

However, such antibiotics are extremely bitter, and even when dissolved in trace quantities in a liquid dosage form are often perceived to be unpalatable.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0032] Preparation of Clarithromycin Tablets Containing 56.8 wt. % Polymer.

IngredientAmount per TabletTablet CoreClarithromycin500 mgMethocel E5LV Premium470 mgMethocel E15LV Premium200 mgMagnesium Stearate 15 mgSilicone Dioxide NF (Syloid-244) 5 mgCoatingMethocel E5 LV Premium 14 mgMethocel E15 LV Premium 6 mgTitanium Dioxide USP 2 mgPolyethylene Glycol 3350 NF 2 mgPurified Waterq.s.

[0033] The clarithromycin, Methocel E5 LV, Methocel E15 LV, silicone dioxide and 5 mg of magnesium stearate were mixed in a 800 L high-shear mixer with an impeller set at 350 rpm and chopper set at 2000 rpm to form a blend. The blend was compacted using a roller compacter. The compacted material was milled using a Flak Crusher equipped with 2.0 mm wire-mesh screen. To the milled blend, 10 mg of magnesium stearate was added and mixed in a V-blender. This blend was compressed into a tablet and the tablets were coated.

example 2

[0034] Preparation of Clarithromycin Tablets Containing 60 wt. % Polymer.

IngredientAmount per TabletTablet CoreClarithromycin 500 mgMethocel K 100LV 130 mgMagnesium Stearate 6.5 mgLactose13.5 mgPurified Waterq.s.CoatingEudragit L100-55 650 mg

[0035] Clarithromycin, Methocel and lactose were mixed to form a powder mixture. Water was added gradually to obtain a uniform granulation. The granulation was dried in an oven at 60° C. for about 45 minutes. The dried granules were passed through a hand screen #16. Magnesium stearate was added to the screened blend and mixed. The final blend was compressed into tablets and coated.

example 3

[0036] Preparation of Clarithromycin Tablets Containing 54.3 wt. % Polymer.

IngredientAmount per TabletTablet CoreClarithromycin 500 mgMethocel K 100LV 130 mgMagnesium Stearate 6.5 mgLactose13.5 mgPurified Waterq.s.CoatingPharmacoat 603 540 mgSodium Bicarbonate  20 mgFumaric Acid  20 mgMagnesium Stearate  5 mg

[0037] The tablets were prepared according to the procedure set forth in Example 2.

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Abstract

An extended-release antibiotic composition comprising at least one antibiotic, and greater than 50 weight percent, based on the total weight of the composition, of a polymer component, wherein said polymer component comprises at least one pharmaceutically acceptable hydrophilic polymer, and said polymer component has a viscosity of less than about 50 cps.

Description

FIELD OF THE INVENTION [0001] The present invention provides an extended-release antibiotic composition comprising at least one antibiotic, and greater than 50 weight percent, based on the total weight of the composition, of a polymer component, wherein said polymer component comprises at least one pharmaceutically acceptable hydrophilic polymer, and said polymer component has a viscosity of less than about 50 centipoise (cps). BACKGROUND OF THE INVENTION [0002] Antibiotics, such as clarithromycin and erythromycin has been used in the treatment of common pediatric infections of the middle ear and upper respiratory tract, as well as certain forms of pneumonia that affects the elderly. Formulations containing an antibiotic are typically administered as immediate-release compositions, two or three times a day, for a regimen of 10-14 days. However, such antibiotics are extremely bitter, and even when dissolved in trace quantities in a liquid dosage form are often perceived to be unpalat...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/24A61K9/28A61K31/7048
CPCA61K9/2054A61K31/7048A61K9/2866A61K9/209A61P31/04
Inventor PATEL, MAHENDRA R.PATEL, BHASKARBHAI C.MATHARU, AMOL SINGH
Owner SANDOZ INC
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